Recalls / Class II
Class IID-0525-2025
Product
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
- Brand name
- Omeprazole
- Generic name
- Omeprazole
- Active ingredient
- Omeprazole
- Route
- Oral
- NDC
- 82009-022
- FDA application
- ANDA075576
- Affected lot / code info
- Lot: C2403017, Exp 12/31/2026
Why it was recalled
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 1476 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-06-30
- FDA classified
- 2025-07-14
- Posted by FDA
- 2025-07-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0525-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.